Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative

This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

GUEST COLUMNISTS

Building Quality Into Radiopharmaceuticals: A Look At EMA's Recent Guideline
The EMA's December 2025 draft guideline on expectations for the quality documentation of radiopharmaceuticals replaces the earlier 2007 guideline and reflects significant developments.
Overcoming 3 Key Challenges Of Working With CDMOs For Radiopharmaceuticals
Radiopharmaceuticals have a level of operational complexity that challenges traditional outsourcing models. Address these three critical challenges early and intentionally.
Selecting The Right eQMS To Maximize Quality Maturity
Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.
How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT
Patient access often gets mischaracterized solely as a cost and pricing issue. A discussion among industry leaders reaches a deeper, more complex conclusion.
FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing
The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.
Validating Candel's BLA-Ready Analytics Profile
The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.
Mapping Candel Therapeutics' Sprint To The BLA Finish Line
Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.
The Hidden Operational Cost Contained In Every Small Molecule Portfolio
The volume of post-approval changes is rising and the manual approaches that have worked until now are no longer adequate. Get ahead of this to spend less and execute faster.

PHARMA OUTSOURCING WHITE PAPERS

Expanding The Capabilities Of Targeted Integration
See the demonstration of precise, site‑specific integration of a 50 kb multi‑gene construct into human iPSCs, overcoming size limits of traditional genome‑engineering approaches.

Standardized Extraction Protocol Per USP <665>: Bridging Regulatory Expectations And Industry Best Practices
View how to implement USP <665> extractables testing, align with global E&L standards, and apply risk-based strategies to ensure regulatory compliance and patient safety.
Solid State Hydrogen Deuterium Exchange To Study Antibody Drug Conjugate Stability
Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based antibody drug conjugates and enhance ADC development processes.
Leak Rate Testing for Freeze Dryers: A Scientific Approach
Explore our innovative approach to establishing leak rate acceptance criteria and ensure the integrity of your freeze-drying processes for sterile pharmaceutical production.
Spray Dried Dispersions In Controlled Release Formulations
Integrating spray dried dispersions with CR strategies addresses poor drug solubility and the need for tailored release kinetics. Explore considerations to ensure stability and sustained supersaturation.
Set Your Cell And Gene Therapy Program Up For Success From Day One
Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.